FDA Considers New Methods To Advance Antimicrobial Clinical Trials

By Kelly Lienhard / December 2, 2019 at 2:57 PM
FDA is looking into new innovations that could increase the speed and accuracy of clinical trials aimed at addressing antimicrobial resistance, an FDA official said. The agency is considering relying more heavily on ordinal endpoints, borrowing information across different body sites, and conducting additional carbapenem-resistant pathogen studies. Increased resistance to antibiotics is an area of growing concern to FDA, the Centers for Disease Control and Prevention (CDC) and other government agencies, as well to hospitals and other key stakeholders. According...

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